NCT04113980

Brief Summary

Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures. Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 1, 2019

Last Update Submit

October 12, 2019

Conditions

Keywords

acute painanxietychildrenblood collectionnursing

Outcome Measures

Primary Outcomes (2)

  • Children Fear Scale

    The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated

    1 minute

  • Wong Baker Face Pain Scale

    The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').

    1 minute

Study Arms (4)

music group

EXPERIMENTAL

The children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over.

Other: music group

kaleidescope group

EXPERIMENTAL

The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.

Other: kaleidoscope group

video group

EXPERIMENTAL

The children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over.

Other: video group

control group

NO INTERVENTION

No intervention was made to children in the control group

Interventions

The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over

music group

The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over

kaleidescope group

The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over

video group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being healthy
  • ability to express himself/herself verbally
  • no analgesic taken in the last 6 hours
  • having no visual or auditory problems

You may not qualify if:

  • chronic disease
  • mental disease
  • neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University

Adıyaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 3, 2019

Study Start

August 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations